Kornimate/medical-research-clean huggingface dataset:
salivary cortisol measurement in corticotrope deficiency substitution with hydrocortisone.

Conditions: Adrenal Insufficiency

Summary: patients with adrenal insufficiency are most often overdosed with hydrocortisone. to date, there is no reliable marker that can reflect the quality of hydrocortisone substitution. salivary cortisol is a good reflection of free plasmatic cortisol. however, salivary contamination with the oral intake of hydrocortisone has been described. the aims of the study are to: * evaluate the frequency of salivary contamination by hydrocortisone taken in tablet form and determine its risk factors. * evaluate the quality of hydrocortisone substitution in patients with corticotrope deficiency.

patients with adrenal insufficiency are most often overdosed with hydrocortisone, as evidenced by the higher frequency of metabolic disorders, osteoporosis and cardiovascular mortality in these subjects compared to healthy subjects. to date, there is no reliable marker that can reflect the quality of hydrocortisone substitution. salivary cortisol is a good reflection of free plasmatic cortisol. however, salivary contamination with the oral intake of hydrocortisone has been described. the aims of the study are to: * evaluate the frequency of salivary contamination by hydrocortisone taken in tablet form and determine its risk factors. * evaluate the quality of hydrocortisone substitution in patients with corticotrope deficiency. it is a cross over clinical trial with three arms: patients taking tablets of hydrocortisone, patients taking capsules of hydrocortisone, and healthy control subjects undergoing one day test. salivary cortisol is measured before, at one, two and four hours after hydrocortisone intake.

Eligibility criteria:
inclusion criteria: -patients with corticotrope deficiency treated with hydrocortisone for at least one year. exclusion criteria: * alcoholism, * morbid obesity, * long standing or uncontrolled diabetes mellitus, * uncontrolled hypothyroidism, * depression, * chronic or acute inflammatory or infectious disease, * neoplasia, * renal or hepatic disease, * malabsorption, * pregnant or breast-feeding women, * treatment with corticosteroids other than hydrocortisone, enzyme inducers or oestrogens.

Keywords: adrenal insufficiency hydrocortisone salivary cortisol pharmacokinetic
microbial colonization of dairy free oral probiotics

Conditions: Microbial Colonization

Summary: the aim of this study is to evaluate the colonization efficacy of probiotic lozenges containing dairy and dairy free probiotic streptococcus salivarius m18, in healthy adults

this is a double-blind, randomized controlled colonization pilot study with no cross over to evaluate the colonization efficacy of two different lozenges containing either dairy or dairy free probiotic bacteria streptococcus salivarius m18. participants will be randomly assigned to one of the 2 groups consuming probiotic lozenge containing dairy free streptococcus salivarius m18 or dairy based streptococcus salivarius m18 over a seven day period. saliva samples will be collected at predetermined time points pre and post intervention. colonization efficacy will be determined by enumerating the probiotic in the saliva samples using standard microbiological techniques.

Eligibility criteria:
inclusion criteria: male or female 18y - 80y age 1. in general good health 18 - 80 years of age. 2. practice good oral hygiene. exclusion criteria: 1. have a history of autoimmune disease or are immunocompromised. 2. are on concurrent antibiotic therapy or regular antibiotic use within last 1 week 3. history of allergy (e.g. dairy).

Keywords: streptococcus salivarius m18 dairy free allergen free probiotic microbial colonization oral probiotic chewable tablet
immunogenicity and safety of gsk biologicals' hbv-mpl vaccine and engerix™-b in healthy adults (15-40 yrs).

Conditions: Hepatitis B

Summary: this study evaluates the safety and immunogenicity of the candidate hbv-mpl vaccine administered to healthy adults aged from 15 to 40 years, according to a 0, 6- month vaccination schedule, with engerix™-b as control administered at 0, 1, 6 months.

at the time of conduct of this study, the sponsor glaxosmithkline was known by its former name smithkline beecham

Eligibility criteria:
inclusion criteria: * age: between 15 and 40 years old. * good physical condition as established by clinical examination and history taking at the time of entry. * female participants who are at risk to become pregnant will be on a contraceptive programme if necessary during the study period. * written informed consent obtained from the subjects aged between 18 and 40 and from the parents/tutor when the subjects are aged between 15 and 17 years. exclusion criteria: * positive titres at screening for anti-hbs antibodies. * elevated serum liver enzymes. * history of significant and persisting hematologic, hepatic, renal, cardiac or respiratory disease. * any acute disease at the moment of entry. * chronic alcohol consumption. * hepatomegaly, right upper quadrant abdominal pain or tenderness. * any chronic drug treatment, including any treatment with immunosuppressive drugs, which in the investigator's opinion, precludes inclusion into the study. * history of allergic disease likely to be stimulated by any component of the vaccine. * simultaneous participation in any other clinical trial. * previous vaccination with a hepatitis b vaccine. * previous vaccination with an mpl containing vaccine. * administration of immunoglobulins in the past 6 months and during the whole study period * simultaneous vaccination one week before and one week after each dose of the study vaccine

Keywords: hepatitis b recombinant hepatitis b vaccine adjuvanted hepatitis b vaccine
mri for assessment of hypoxia-induced prostate cancer aggressiveness

Conditions: Prostatic Neoplasms; Genital Neoplasms, Male; Prostatic Diseases

Summary: the purpose of the study is to combine and correlate data from morphological and functional mri, molecular signatures of tumor hypoxia, the presence of micrometastases and tumor hypoxia with the goal being predicting of prostate cancer aggressiveness.

a prospective study including 180 consecutive patients with pca referred to oslo university hospital, radiumhospitalet, for surgical treatment. in vivo functional mri examination will be performed within a few days prior to robot-assisted radical prostatectomy (ralp). for a subgroup of patients facbc pet will also be acquired prior to prostatectomy. a subgroup of intermediate and high-risk patients (d'amico risk classification) will prior to surgery receive an intravenous infusion of the hypoxia-marker pimonidazole (hypoxyprobe™-1)\*. during surgery, bone marrow aspiration and blood collection will be performed for assessment of disseminated and circulating tumor cells. high-risk patients will undergo intraoperative lymph node dissection. tumor tissue for molecular analyses will be sampled from prostate specimen prior to fixation. prostate specimen and regional lymph nodes will be histopathologically examined for t- and n-classification, gleason grade, presence of micrometastasis and areas of hypoxia. histological and molecular findings will be correlated to mri and pet findings and clinical data. patients will be longitudinally followed to assess long-time clinical outcome (recurrence, metastatic disease, death). \*from 2013 oral administration is used.

Eligibility criteria:
inclusion criteria: * patients suitable for surgery with confirmed prostate cancer, gleason grade ≥ 3 * patient has received no prior treatment for prostate cancer. * patient has adequate renal function: estimated creatinine clearance ≥ 60 ml/minute. * patient must sign written informed consent according to the protocol approved by the regional ethics committee. exclusion criteria: * patient with contraindication to mr or mr contrast media according to clinical practice. * patients who want to withdraw for any reason during the study. * patients previously undergone pelvic surgery or radiation therapy

Keywords: functional magnetic resonance imaging prostate cancer facbc pet hypoxia imaging
vestibulotherapy: vestibular impact on learning

Conditions: Vestibular Disorder; Educational Problems; Attention Deficit Disorder

Summary: research question: will daily engagement in activities tailored to the evidence-based vestibular research result in improved attention and learning outcomes for children ages 6-9 years of age after an 8-week classroom-based intervention?

"vestibulotherapy" is an emerging frame of reference aiming to help neurotypical children with under-performing vestibular systems develop neural pathways supporting communication and learning. theory based upon systematic review: given adequate vestibular activation through targeted activities (in an otherwise under-performing vestibular system), myelination and neuroplasticity propagate along learning pathways leading to greater neural connectivity and efficiency for sequencing, ordinance, attention, memory, body schema, spatial cognition, executive function, and interoception. as a result of prescribed vestibular interventions and gained attributes supporting learning, students will experience increased academic growth and success as outlined by the following model.

Eligibility criteria:
inclusion criteria: * neurotypical development * between the ages of 6-10 years of age * performance challenges in school in the areas of math, spelling, organization, sequencing, attention, or engagement * demonstrate attributes of vestibular dysfunction per the vestibular profile * may have add or adhd * may have challenges with speech articulation * good potential for learning and engaging in prescribed interventions exclusion criteria: * neurodiverse development (with the exception of adhd or add) * absence of vestibular challenges * absence of learning challenges. * unable to participate in interventions on a routine basis due to attendance or other limitations.

Keywords: vestibular occupational therapy children educational outcomes
a study to evaluate lucitanib in combination with nivolumab in patients with a solid tumor

Conditions: Advanced Solid Tumor; Gynecologic Cancer

Summary: this is an open-label, phase 1b/2 study to determine the recommended dose of lucitanib in combination with nivolumab in patients with an advanced solid tumor (phase 1b); followed by evaluation of the safety and efficacy of lucitanib and nivolumab in patients with an advanced gynecological solid tumor (phase 2) and evaluate the effects of dosing under fasting or fed state (food effect)


Eligibility criteria:
general inclusion criteria: * ≥ 18 years of age * adequate organ function * life expectancy ≥ 3 months * women of childbearing potential must have a negative serum pregnancy test * advanced/metastatic solid tumor (phase 1b) * availability of tumor tissue at screening * ecog performance status of 0 to 1 * measurable disease (recist v1.1) (phase 2) * advanced, recurrent, or metastatic gynecological solid tumor (phase 2) * willing and able to fast, and to eat a high-fat breakfast (food effect) general exclusion criteria: * prior treatment with lucitanib * active second malignancy * active central nervous system brain metastases * pre-existing duodenal stent or any gastrointestinal disorder * known history of hiv or aids; positive result of hepatitis b or c viruses * evidence of interstitial lung disease, active pneumonitis, myocarditis, or history of myocarditis * active, known or suspected autoimmune disease (eg, autoimmune hepatitis) * condition requiring systemic treatment with corticosteroids or other immune suppressive medications * unstable or uncontrolled hypertension (bp ≥ 140/90 mmhg) * prior treatment with a vegfr-tyrosine kinase inhibitor (phase 2)

Keywords: lucitanib nivolumab antineoplastic agents immunological antineoplastic agents tyrosine kinase inhibitors gynecologic neoplasms checkpoint inhibitor ovarian cancer fallopian tube cancer primary peritoneal cancer endometrial cancer clear cell cancer cervical cancer pd-1 inhibitor immuno-oncology
concentration of itraconazole solution in nasal secretions

Conditions: Sinusitis

Summary: the primary objective of this study is to determine the concentration of itraconazole irrigation in nasal mucous specimens via collection and high-performance liquid chromatography (hplc) assay. eight (8) patients with chronic rhinosinusitis (crs) and two (2) healthy controls will be enrolled in the initial evaluation. after an initial control nasal specimen, followed by seven days of twice daily topical itraconazole irrigation, nasal specimens will be collected at varying time intervals and the concentrations measured. the primary endpoint is development of a reliable collection and assay technique with concentration curves over time of topically administered itraconazole. a secondary endpoint is to determine if the concentrations measured achieve a mean inhibitory concentration (mic90) to commonly cultured fungal species in the nose.

this is a pilot study for the purpose of gathering concentration data on a commonly used topical antifungal solution of itraconazole. crs patients that meet the defined inclusion criteria will begin topical itraconazole antifungal irrigations on day 1. this will consist of itraconazole in sterile water 100 mg/1000 ml, irrigating each nostril with 20 ml of solution twice daily, with a bulb syringe as directed. the patient will return on day 7 for repeat examination and nasal secretion collection. two patients will be randomly selected to have blood drawn at the completion of day 7 testing to determine the concentration of itraconazole in the blood.

Eligibility criteria:
inclusion criteria: general: * greater than or equal to eighteen years of age. * patient must be willing to be available and comply with all scheduled procedures as defined in the protocol. * patients that have been felt to be candidates for topical itraconazole therapy and would have been started on the therapy regardless of study inclusion medical: * crs defined by american academy of otolaryngology - head and neck surgery (aao hns) guidelines controls: * do not meet crs definitions. no acute sinusitis within past 4 weeks. no previous surgery for rhinosinusitis. no history of allergic rhinitis or other rhinologic disorders. exclusion criteria: general: * previous use of a topical antifungal nasal irrigation within the past 2 weeks or a systemic antifungal medication within the past 3 months. medical: * history of cystic fibrosis, immunodeficiency, immotile cilia syndrome, clinical or radiographic suspicion for fungal mycetoma or invasive fungal sinusitis * pregnancy - female patients of child bearing age will undergo a pregnancy test, if positive they will be excluded * history of liver disease * history of congestive heart failure * allergy or sensitivity to itraconazole, or other azole antifungals, or any other ingredient in the preparation.

Keywords: itraconazole
safety and effectiveness of cortical stimulation in the treatment of stroke patients with upper extremity hemiparesis

Conditions: Stroke; Hemiparesis

Summary: the purpose of this study is to assess the safety and effectiveness of cortical stimulation delivered concurrent with rehabilitation activities to enhance motor recovery in patients suffering from hemiparesis affecting the upper extremity following a stroke.

stroke is a leading cause of serious, long-term disability in the united states. according to the american stroke association, the prevalence of stroke in the u.s. is approximately 4.8 million with approximately 700,000 additional strokes occurring annually. the 2001 overall death rate for stroke was 58%. of those who survive, 30 to 50 percent do not regain functional independence, 15 to 30 percent are permanently disabled, and 20% require institutional care at three months after onset. the most common neurological deficit among these stroke survivors, and thus a substantial contributor to post-stroke disability, is a motor weakness on one (hemiparesis) side of the body. presently, the only treatment available for patients with motor deficits is rehabilitative therapy. however, many patients are not responsive to standard rehabilitative therapy or achieve a less than satisfactory improvement in function. the primary objective of this study is to determine the safety and effectiveness of targeted sub-threshold epidural cortical stimulation delivered concurrent with rehabilitation activities to enhance motor recovery in patients suffering from hemiparesis (a motor weakness in one half of the body) affecting the upper extremity (shoulder, arm, wrist, hand) following a stroke. in addition to evaluating changes from baseline level, safety and efficacy measures will be compared to patients who undergo the same rehabilitation activities but without cortical stimulation. the two study groups will be compared to determine the degree to which motor function of the affected limb can be improved beyond rehabilitation alone by epidural stimulation of a targeted cortical region.

Eligibility criteria:
inclusion criteria: * subjects must have an ischemic stroke. * moderate to moderately severe upper-extremity hemiparesis. * aged 21 years or older. exclusion criteria: * primary hemorrhagic stroke. * any additional stroke associated with incomplete motor recovery. * any neurologic or physical condition impairing function of the target extremity. * history of seizure disorder. * history of spinal cord injury, traumatic brain injury, or spontaneous subdural or epidural hematoma that has resulted in a neurologic deficit. * contraindication to magnetic resonance (mr) imaging.

Keywords: motor cortex electrical stimulation ischemic stroke upper extremity hemiparesis rehabilitation motor recovery functional mri
evaluation of oxxyneags in acute glycemic regulation on light hyperglycemic subjects

Conditions: Hyperglycemia, Postprandial

Summary: this study aims to evaluate and select the best combination of polyphenol and white kidney bean ingredients in the acute glycemic modulation after a complete meal by measuring blood glucose and insulin.


Eligibility criteria:
inclusion criteria: * glycemia: 100-125mg/dl * both sexes * overweight bmi range (27-32) * age: 20-50 years old exclusion criteria: * metabolic/chronical disease * menopausal women * being pregnant, breastfeeding or wanting to have a baby * former obese with a history of yoyo effect * have been involved in a weight loss program in the past 12 months or subjected to weight reduction surgery * having started or quit smoking, having a high alcohol consumption * have in the past been in a long-term antibiotherapy (1 month or more) and/or a regular antibiotherapy in the past 12 months * allergy to olive, artichoke, black currant, grapefruit, grape, white kidney bean, olive, pomegranate.
mobile technology and online tools to improve asthma control in adolescents - usability

Conditions: Asthma

Summary: this project will fully develop and preliminarily validate campair, an empirically-based dynamic e-health intervention (based on the evidence-based asma) to assist adolescents with uncontrolled asthma to learn how to manage their illness and improve their asthma control. in addition to developing a highly novel product for adolescents with asthma, the research proposed for this project will address unique scientific questions. despite the high asthma prevalence among adolescents, few interventions have specifically targeted adolescents. this study is innovative in that it is among the few to focus on adolescents, who are often overlooked by the healthcare system. this research will assess factors associated with successful implementation of campair, thereby providing new information regarding how e-health interventions can be effectively developed and implemented for use with adolescents with asthma.

this project will fully develop and preliminarily validate campair, an empirically-based dynamic e-health intervention (based on the evidence-based asma) to assist adolescents with uncontrolled asthma to learn how to manage their illness and improve their asthma control. in addition to developing a highly novel product for adolescents with asthma, the research proposed for this project will address unique scientific questions. despite the high asthma prevalence among adolescents, few interventions have specifically targeted adolescents. this study is innovative in that it is among the few to focus on adolescents, who are often overlooked by the healthcare system. this research will assess factors associated with successful implementation of campair, thereby providing new information regarding how e-health interventions can be effectively developed and implemented for use with adolescents with asthma. to ensure the software and website function as intended, investigators will systematically test each of the seven campair modules with target end users. participants will review one module per week for seven weeks. as part of each module, participants will also complete a daily asthma checklist. following the review of each module, participants will be prompted to complete measures assessing technology acceptability and usability and product quality. results will be used to modify and finalize the user interface and navigation to maximize usability. results are expected to support that all participants find the campair product to be of high quality and technical acceptability. participants are expected to rate the usability and relevance of the campair product highly. all participants are expected to advocate use of the product and recommend continued development and testing.

Eligibility criteria:
inclusion criteria: * between ages 13 - 18 years * prior asthma diagnosis * use of a prescribed asthma medication in the past 12 months
role of three dimensional ultrasound in the diagnosis of septate uterus

Conditions: Infertility

Summary: congenital uterine anomalies are found in 8% of infertile women and 24.5% of infertile women with a history of recurrent miscarriage, with septate and sub-septate uterus being the most common anomalies in these women, also, septate uterus is the commonest anomaly found in infertile women requiring assisted reproductive technology. published data showed improved cumulative pregnancy rate and live birth rate, and a significant reduction in miscarriage rate in in vitro fertilization women after hysteroscopic metroplasty of both small and large septate compared to non-operated women. investigators hypothesized that trans-vaginal three dimensional ultrasound will be superior to hystro-salpingography for the differentiation between arcuate and septate uterus in infertile women scheduled for in vitro fertilization.


Eligibility criteria:
inclusion criteria: * women with primary infertility, * an indication for ivf and * suspected arcuate or septate uterus diagnosis based on hysterosalpingography . exclusion criteria: * were confirmed uterine abnormality by prior office hysteroscopy